Canada Health Authority Interactions

Canada Health Authority Interactions - Overview

Regulatory agency interactions are key in achieving a positive impact on the approval timelines and overall costs. Since the final decision on drug product approvals lies with Health Canada, it is important to ensure that the interactions with the Agency (whether face-to-face, in writing, or via teleconference) are conducted efficiently throughout the Regulatory process.

Sponsors can request Canada Health Authority interactions to understand the bioequivalence study design and other expectations for the content, format, and level of information required to be included in the pre-submission meetings. Health Canada provides generic applicants with an opportunity to discuss and clarify the expectations of the development plans and meetings to help applicants identify the potential risks and issues related to their ANDS applications so that the appropriate risk-mitigation strategies can be implemented to minimize the approval time.

Freyr, with expertise in handling end-to-end registration activities and Canada Health Authority interactions, can assist applicants in all types of formulations, Regulatory submissions, procedural guidance, and understanding the concerns along with the compilation of appropriate responses with scientific justification to avoid further queries.